(79 days)
The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.
The Quantum Perfusion Hybrid System is a system, including a blood reservoir consisting of an hardshell and softshell reservoir. The combination of defoaming bodies and filtering media of venous/vent and cardiotomy side allows both the filtration of debris and the retention of air bubbles. Product configuration includes, together with the Hybrid System, dedicated spare parts: an adapter 1/2" – 3/8"; a spare cap set; a blood sampling set. The device is intended to be used for periods up to six hours. The Quantum Perfusion Hybrid System is a sterile device with non-pyrogenic fluid pathways, sterilized by ethylene oxide, conceived for single use only and is not to be re-sterilized by the user; the device has a declared shelf life of 2 years.
The provided text is a 510(k) summary for a medical device (Quantum Perfusion Hybrid System) and primarily focuses on proving substantial equivalence to predicate devices through non-clinical testing. It does not contain information about a study proving device performance against specific acceptance criteria for an AI/software-driven device.
Therefore, I cannot provide the requested information, as the document details a traditional medical device submission, not one related to an AI/ML component with associated performance studies (MRMC, standalone algorithm, ground truth establishment, etc.). The document explicitly states: "No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices." and "No animal studies have been performed except for mandatory biocompatibility tests...".
The non-clinical testing mentioned is focused on general device performance for a cardiopulmonary bypass blood reservoir, such as pressure drop, mechanical resistance, air handling, and filtration efficiency, verifying it meets established engineering requirements for this type of device, which are inherent to the device's design and function rather than a set of statistical acceptance criteria that would typically be associated with an AI/ML algorithm's performance.
To answer your request, a document detailing an AI/ML device would be needed, specifically discussing its performance study, acceptance criteria, test set details, ground truth, and potentially MRMC study results.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 18, 2024
Spectrum Medical S.r.1. Raffaella Tommasini QA&RA Director Via di Mezzo, 23 Mirandola, MO 41037 Italy
Re: K241206
Trade/Device Name: Ouantum Perfusion Hybrid System Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN Dated: April 29, 2024 Received: April 30, 2024
Dear Raffaella Tommasini:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K241206
Device Name Quantum Perfusion Hybrid System
Indications for Use (Describe)
The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Spectrum Medical. The text "Spectrum" is in blue, followed by a red heartbeat symbol. The word "Medical" is in blue and follows the heartbeat symbol.
510(K) SUMMARY
l. SUBMITTER
| Submitter Name: | Spectrum Medical S.r.l. |
|---|---|
| Submitter Address: | Via di Mezzo, 23 41037 Mirandola (MO) Italy |
| Contact Person: | Raffaella Tommasini, QA&RA DirectorSpectrum Medical S.r.l. |
| Phone: | +39 0535 1803050 |
| e-mail: | raffaella.tommasini@spectrummedical.com |
| Fax: | +39 0535 1803051 |
| Date Summary Prepared: | April 29, 2024 |
and Vascular Devices)
ll. DEVICE
Proprietary Name: Common Name: Classification Name: Regulatory Class: Product Code: Panel:
Quantum Perfusion Hybrid System Hybrid System Reservoir, Blood, Cardiopulmonary Bypass ll DTN Office office office Cardiovascular Devices, Health Technology 2 (OHT2) / Division of Health Technology 2 B (Circulatory Support, Structural
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Image /page/4/Picture/0 description: The image shows the logo for Spectrum Medical. The text "Spectrum" is in blue, followed by a red line that resembles a heart rate monitor. The word "Medical" is in blue and follows the red line.
PREDICATE DEVICES AND REFERENCE DEVICES III.
| Predicate Device | |
|---|---|
| Proprietary Name: | INSPIRE 8F DUAL hollow Fiber Oxygenator withIntegrated arterial filter and hardshellvenous/cardiotomy reservoir |
| Registered Establishment Name: | Sorin Group Italia S.r.l. |
| Classification Name: | Cardiopulmonary Bypass Oxygenator, Reservoir,Blood, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DTN,DTZ |
| 510(k) Number: | K122844 |
Reference Device
| Proprietary Name: | Affinity Fusion™ Oxygenator with IntegratedArterial Filter and Cardiotomy/Venous Reservoirwith Balance™ Biosurface |
|---|---|
| Registered Establishment Name: | Medtronic Inc. |
| Classification Name: | Cardiopulmonary bypass Oxygenator |
| Regulatory Class: | II |
| Product Code: | DTZ |
| 510 (k) Number: | K183490 |
DEVICE DESCRIPTION IV.
The Quantum Perfusion Hybrid System is a system, including a blood reservoir consisting of an hardshell and softshell reservoir.
The combination of defoaming bodies and filtering media of venous/vent and cardiotomy side allows both the filtration of debris and the retention of air bubbles. Product configuration includes, together with the Hybrid System, dedicated spare parts:
- . an adapter 1/2" – 3/8";
- a spare cap set;
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Image /page/5/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by "Medical" in the same color. A red line resembling an electrocardiogram (EKG) is placed between the two words, adding a medical connotation to the logo.
- . a blood sampling set.
The device is intended to be used for periods up to six hours.
The Quantum Perfusion Hybrid System is a sterile device with non-pyrogenic fluid pathways, sterilized by ethylene oxide, conceived for single use only and is not to be re-sterilized by the user; the device has a declared shelf life of 2 years.
V. INTENDED USE / INDICATIONS FOR USE
The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.
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Image /page/6/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by a red heartbeat symbol. The word "Medical" is written in blue after the heartbeat symbol.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Device | Proposed Device – QuantumPerfusion Hybrid System | Predicate Device – INSPIRE 8F DUALhollow Fiber Oxygenator withintegrated arterial filter andhardshell venous/cardiotomyreservoir | Reference Device – Affinity Fusion™Oxygenator with Integrated ArterialFilter and Cardiotomy/VenousReservoir with Balance™ Biosurface |
|---|---|---|---|
| Name | Quantum Perfusion Hybrid System | INSPIRE 8F DUAL hollow FiberOxygenator with integrated arterialfilter and hardshellvenous/cardiotomy reservoir | Affinity Fusion™ Oxygenator withIntegrated Arterial Filter andCardiotomy/Venous Reservoir withBalance™ Biosurface |
| 510(k) Number | To be assigned | K122844 | K183490 |
| Device description | The Quantum Perfusion HybridSystem (HR04V-A0) mainly consists oftwo separate chambers: the firstchamber collects and filters the non-activated blood coming from patient'svein and the intracardiac suction; Thesecond chamber collects and filtersthe activated blood coming from theoperating field through thoracic andgeneral suction (cardiotomy line). Thedevice can also be used post-operatively for chest drainage. | The INSPIRE 8F DUAL is a highefficiency microporous hollow fibermembrane oxygenator integratedwith an arterial filter and a heatexchanger (INSPIRE 8F M) andconnected to a hardshellvenous/cardiotomy reservoir(INSPIRE HVR DUAL). A molded fillingjoint connects the oxygenator to thereservoir.The device can be operated at flowrates up to 8 liters per minute (l/min).The hollow fiber membraneoxygenator provides oxygenation and | The Affinity Fusion Oxygenator withIntegrated Arterial Filter (OXY) andBalance Biosurface is a single use,microporous, hollow-fiber, gas-exchange device with plasma-resistant fiber and integrated heatexchanger and filter. The OXY isbonded on its primary bloodcontacting surfaces with anonleaching biocompatible surface toreduce platelet activation andadhesion and preserve plateletfunction. |
| Device | Proposed Device - Quantum Perfusion Hybrid System | Predicate Device - INSPIRE 8F DUAL hollow Fiber Oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir | Reference Device - Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface |
| The Quantum Perfusion Hybrid System must be used during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours and can be operated up to 8 liters per minute (l/min). | carbon dioxide removal from venous blood or suction blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The integrated arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage. | The Affinity Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the filtered venous blood. With the exception of the filter, the CVR is bonded on its primary venous blood contacting surfaces with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. | |
| Regulation # | 870.4400 | 870.4350 (oxygenator)870.4400 (reservoir) | 870.4350 (oxygenator)(Please note that some variants included in K183490 present as additional component a reservoir, for which 870.4400 is applicable) |
| Regulation Name | Reservoir, Blood, Cardiopulmonary Bypass | Cardiopulmonary Bypass Oxygenator Reservoir, Blood, Cardiopulmonary Bypass | Cardiopulmonary Bypass Oxygenator (Please note that some variants included in K183490 present as additional component a reservoir) |
| Device | Proposed Device - QuantumPerfusion Hybrid System | Predicate Device - INSPIRE 8F DUALhollow Fiber Oxygenator withintegrated arterial filter andhardshell venous/cardiotomyreservoir | Reference Device - Affinity Fusion™Oxygenator with Integrated ArterialFilter and Cardiotomy/VenousReservoir with Balance™ Biosurface |
| Product Code | DTN | DTZ (oxygenator), DTN (reservoir) | DTZ (oxygenator)(Please note that some variantsincluded in K183490 present asadditional component a reservoir, forwhich DTN product code is applicable) |
| Classification | II | II | II |
| Indication for Use | The Quantum Perfusion HybridSystem is intended to collect, defoamand filter venous and suction bloodduring cardiopulmonary bypass. Thedevice is intended to be used forperiods up to six hours. The device isintended for adult patients. | INSPIRE HVR DUAL HardshellVenous/Cardiotomy Reservoir isintended for use in adult and smalladult surgical procedures requiringcardiopulmonary bypass. It collects,defoams and filters venous blood andsuction blood.INSPIRE HVIR DUAL can be used post-operatively for chest drainage.INSPIRE HVIR DUAL is intended to beused for 6 hours or less. | The Affinity Fusion™ Oxygenator withIntegrated Arterial Filter withBalance™ Biosurface is intended to beused in an extracorporeal perfusioncircuit to oxygenate and removecarbon dioxide from the blood and tocool or warm the blood during routinecardiopulmonary bypass (CPB)procedures up to 6 hours in duration.The Affinity Fusion™ Oxygenator withIntegrated Arterial Filter withBalance™ Biosurface is designed tofilter from the circuit microembolilarger than the specified micron sizefor periods up to 6 hours during CPBsurgery.The Affinity Fusion™Cardiotomy/Venous Reservoir with |
| Device | Proposed Device - QuantumPerfusion Hybrid System | Predicate Device - INSPIRE 8F DUALhollow Fiber Oxygenator withintegrated arterial filter andhardshell venous/cardiotomyreservoir | Reference Device - Affinity FusionTMOxygenator with Integrated ArterialFilter and Cardiotomy/VenousReservoir with BalanceTM Biosurface |
| BalanceTM Biosurface is intended to beused in an extracorporeal perfusioncircuit to collect venous andcardiotomy suctioned blood duringroutine cardiopulmonary proceduresup to 6 hours in duration. The CVR isalso intended for use during vacuum-assisted venous drainage (VAVD)procedures.The Affinity FusionTMCardiotomy/Venous Reservoir withBalanceTM Biosurface is also intendedfor use after open heartsurgery to collect autologous bloodfrom the chest and to asepticallyreturn the blood to the patient forblood volume replacement. | |||
| Target population | Adult | Adult and small adult | Adult |
| Main contacting material | Coating: PhosphorylcholineFiltering media: Polyester (PET)Defoaming body: Polyurethane (PU)Housing: Copolyester | Coating: PhosphorylcholineFiltering media: Polyester (PET)Defoaming body: Polyurethane (PU)Housing: Polycarbonate (PC) | Coating: Hydrophilic biosurfacewithout heparinFiltering media: Information onmaterial N.A. |
| Device | Proposed Device - QuantumPerfusion Hybrid System | Predicate Device - INSPIRE 8F DUALhollow Fiber Oxygenator withintegrated arterial filter andhardshell venous/cardiotomyreservoir | Reference Device - Affinity Fusion™Oxygenator with Integrated ArterialFilter and Cardiotomy/VenousReservoir with Balance™ Biosurface |
| Defoaming body: Polyurethane (PU) | |||
| Housing: Copolyester (Tritan) | |||
| Overall volume capacity [ml] | 4300 | 4500 | 4500 |
| Min operating level [ml] | 150 | 150 | 200 |
| Max venous blood flow rate[I/min] | 8 | 8 | 7 |
| Min venous blood flow rate[I/min] | 1 | 20.5 (up to 2h max duration time)1 | 1 |
| Cardiotomy capacity [ml] | 1100 | 1300 | NA |
| Venous section filtrationporosity [µm] | 40 | 41 | 105 |
| Suitable for VAVD | Yes | Yes | Yes |
| Venous Blood Connector | Inlet: 1/2" (12,7mm) | Inlet: 1/2" (12,7mm) | Inlet: 1/2" with 3/8" adapter |
| Type | Outlet: 3/8" (9.525mm) | Outlet: 3/8" (9.525mm) | Outlet: 3/8" |
| Single-use | Yes | Yes | Yes |
| Sterile Condition | Sterile | Sterile | Sterile |
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Image /page/7/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by a red line that resembles a heart rate monitor. The word "Medical" is written in blue after the red line.
Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com
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Image /page/8/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by a red line that resembles a heartbeat. The word "Medical" is written in blue after the red line.
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Image /page/9/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by a red line that resembles an EKG. The word "Medical" is written in blue after the red line.
Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com
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Image /page/10/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by a red line that resembles a heart rate monitor. The word "Medical" is written in blue after the red line.
1 According to manufacturer's IFU.
Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com
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Image /page/11/Picture/0 description: The image shows the logo for Spectrum Medical. The text "Spectrum" is in blue, followed by a red line that resembles a heartbeat. The word "Medical" is in blue and follows the red line.
Based on the indications for use, main technological characteristics and results of nonclinical testing, subject device has been demonstrated to be appropriate for its intended use and is considered substantially equivalent to legally marketed predicate and reference devices (K122844 and K183490 respectively) according to FDA's Guidance "Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," issued July 28, 2014.
Furthermore, in-vitro performance tests have been performed to demonstrate that the proposed device does not raise any new issues in terms of product's safety or effectiveness as compared to predicate and reference devices.
VII. PERFORMANCE DATA
NON-CLINICAL TESTING
The following non-clinical testing was performed to support the substantial equivalence to predicate devices. These testing included biocompatibility evaluation, mechanical and performance verification, labeling and Instructions for Use (IFU), and verification and validation tests. All testing passed by meeting the established requirements set for the use of the devices.
The following areas have been tested and/or evaluated:
- l Performance tests, taking into account:
- ISO 15674:2016+A1: 2020 Cardiovascular implants and artificial organs o — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags;
- Guidance for Extracorporeal Blood Circuit Defoamer 510(k) o Submissions; Final Guidance for Industry and FDA, dated November 29, 2000.
Tests are mainly related to:
- -Device pressure drop;
- -Temperature Probe Verification;
- Mechanical Resistance of Connectors; -
- -Static Integrity of The Device;
- Coating Coverage and Durability; -
- -Mechanical Blood Cell Damage;
- Air Handling, Clots Inspection and Defoaming Efficiency; -
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Image /page/12/Picture/0 description: The image shows the logo for Spectrum Medical. The text "Spectrum" is in blue, followed by a red line that resembles a heartbeat. The text "Medical" is in blue and follows the red line.
- -Static and Dynamic Priming Volume;
- -Breakthrough Time and Volume;
- -Filtration Efficiency.
- -Evaluation of product shelf life;
- -Validation of the EtO Sterilization process, according to ISO 11135 [Recognition Nr.: 14-529],
- -Packaging Validation tests, according to ISO 11607-1:2019 [Recognition Nr. 14-530],
- -Biocompatibility of the finished product, according to ISO 10993-1:2018 [Recognition Nr. 2-258] and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Animal Study
No animal studies have been performed except for mandatory biocompatibility tests according to International Standard ISO 10993-1:2018 [Recognition Nr. 2-258] and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Clinical Testing
No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices.
VIII. CONCLUSIONS
Based on the indications for use, main technological characteristics and results of nonclinical testing, the subject device has been demonstrated to be appropriate for its intended use and considered substantially equivalent to predicate and reference devices (K122844 and K183490 respectively).
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.